Paclitaxel in Treating Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00111904
First received: May 26, 2005
Last updated: December 13, 2011
Last verified: June 2009
  Purpose

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel works in treating patients with unresectable locally advanced or metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Drug: paclitaxel-loaded polymeric micelle
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Genexol -PM in Patients With Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Best overall response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Clinical benefit [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: May 2005
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the time to progression and time to treatment failure in patients with unresectable locally advanced or metastatic epithelial carcinoma of the pancreas treated with paclitaxel loaded polymeric micelle (Genexol^®-PM).
  • Determine the best overall response rate and duration of response in patients treated with this drug.
  • Determine the overall survival of patients treated with this drug.
  • Determine the clinical benefit and safety of this drug in these patients.

OUTLINE: Patients receive paclitaxel loaded polymeric micelle (Genexol^®-PM) IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed epithelial carcinoma of the pancreas

    • Unresectable* locally advanced or metastatic disease NOTE: *Documented by high-quality contrast-enhanced CT scan
  • No known or clinical evidence of CNS metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ
  • No unstable or serious medical condition
  • No psychiatric disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for pancreatic cancer

    • Prior fluorouracil as a radiosensitizer allowed

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 6 weeks since prior radiotherapy for pancreatic cancer

    • Disease must have progressed after completion of radiotherapy

Surgery

  • More than 14 days since prior major surgery and recovered

Other

  • More than 30 days since prior investigational agents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111904

Locations
United States, Florida
Florida Cancer Specialists - Bonita Springs
Bonita Springs, Florida, United States, 34135
United States, Illinois
Midwest Cancer Research Group, Incorporated
Skokie, Illinois, United States, 60077
United States, Louisiana
Louisiana Oncology Associates - Lafayette
Lafayette, Louisiana, United States, 70506
United States, New York
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, United States, 10011
United States, Texas
Southwest Regional Cancer Center - Central
Austin, Texas, United States, 78705
Sponsors and Collaborators
Theradex
Investigators
Study Chair: John S. MacDonald, MD Beth Israel Comprehensive Cancer Center - West Side Campus
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00111904     History of Changes
Other Study ID Numbers: CDR0000433513, TARGET-S04-10485, WIRB-20050099
Study First Received: May 26, 2005
Last Updated: December 13, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III pancreatic cancer
recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014